A randomized double blind placebo-controlled trial: comparison of azithromycin with doxycycline prophylaxis against leptospirosis in human in an endemic area
Objectives: chemo-prophylaxis in leptospirosis, Design: The study population will include all persons more than 18 y/o, will work in the paddy field(some districts of sari as leptospirosis endemic area in north of Iran) during the study period. Individuals in the paediatric age group will not be included. They will be entered in three groups( azithromycin, doxycycline and placebo group). Sample size will be 90 participants in each group. Researchers and participants are blind to the study and randomization will be upon randomization numbers. Method: Before intervention we will draw sample for IgG antileptospira and positive participants will exclude from study.After randomized selection individuals will receive azithromycin 500mg, doxycycline 200mg weekly and placebo from 1 week before starting work, during and 4 weeks after that in three groups chronologically. During this time all persons will be monitor for any symptoms and signs related to leptospirosis through questionnaire by team members in health center of related place and if any person developed symptom, IgM antileptospira will be check at 2-3 week. Screening test (ELISA) for leptospirosis will be done for all individuals in 3 groups at 6 and 12 weeks of the study too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052322383N1
Registration date:2016-06-29, 1395/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Ahmad Alikhani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 6715
Email address
a.alikhani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Mazandaran University of Medical Sciences,
Expected recruitment start date
2015-05-25, 1394/03/04
Expected recruitment end date
2015-10-25, 1394/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized double blind placebo-controlled trial: comparison of azithromycin with doxycycline prophylaxis against leptospirosis in human in an endemic area
Public title
clinical trial azithromycin versus doxycycline chemoprophylaxis in leptospirosis in farmers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria
All persons residing in endemic area of this disease and will supposed to work in the paddy field after taking a verified consent";" All persons in the range of 18- 65 years old";" Negative screening test for leptospirosis ";" Agree to apply the doxycycline / azithromycin / placebo for all the times of paddy work ";" Willing to regular monitoring for clinical manifestation";" Willing to regular monitoring for three intermittent screening testing";" Agree to report daily water contact";" Agree to consult the related physician prior to taking any medication";" No history of allergies to azithromycin or related compounds";" No history of allergies to doxycycline or related compounds
Exclusion criteria:All persons who have positive first screening test for leptospirosis ";"When the persons have hypersensitivity to azithromycin and doxycycline in history ";" Pregnant women for doxycycline group";" Severe adverse reaction for example; severe photosensitivity due to doxycycline";"Severe adverse reaction to azithromycin";"All persons who don’t agree to enroll in the research";"All persons who don’t agree consent form
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization number table
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mazandaran University of Medical Sciences
Street address
Jouybar three way, Sari, Mazandaran
City
Sari
Postal code
48471-91971
Approval date
2015-05-19, 1394/02/29
Ethics committee reference number
882.IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
leptospirosis
ICD-10 code
A27
ICD-10 code description
A27.8,A27.9
Primary outcomes
1
Description
fever,body pain,red eye,calf pain,icter
Timepoint
0.6,12 week for IgG and 2nd week after developing disease for IgM
Method of measurement
questionnaire and ELISA
2
Description
lab. data:thrombocytopenia.CPK,IgG,IgM
Timepoint
during the study, from beginning of prophylaxis and placebo, IgM Antileptospira checking 2-3 weeks after for participants will develop symptoms and IgG checking for all at zero,6 and 12 weeks
Method of measurement
questionnaire and ELISA
Secondary outcomes
1
Description
nausea,vomiting,esophagitis.photosensitivity
Timepoint
Drug consumption periods
Method of measurement
Interview
Intervention groups
1
Description
intervention group 1 : will receive azithromycin 500mg weekly from 1 week before starting work, during and 4 weeks after that.
Category
Prevention
2
Description
control group :will receive placebo( methyl cellulose crystalline manufactured by Iran daru company)
Category
Prevention
3
Description
intervention group 2: will receive doxycycline 200mg weekly from 1 week before starting work, during and 4 weeks after that.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital in Ghaemshahr
Full name of responsible person
Dr Zameni
Street address
Ghaemshahr, yoosef reza st., Razi hospital
City
Ghaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Esmaeeli
Street address
Research Vice Chancellor, Moallem st., Sari, Mazandaran
City
Sari
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Antimicrobial Resistance Research Center
Full name of responsible person
Dr. Zameni
Position
Infectious Diseases Assistant
Other areas of specialty/work
Street address
Razi Hospital, Yoosef Reza st., Ghaemshahr
City
Ghaemshahr
Postal code
Phone
+98 114221801820
Fax
Email
pzameni3@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Antimicrobial Resistance Research Center
Full name of responsible person
Dr.Zameni
Position
Infectious diseases Assistant
Other areas of specialty/work
Street address
Razi Hospital, Yoosef Reza st., Ghaemshahr
City
Ghaemshahr
Postal code
Phone
+98 114221801820
Fax
Email
pzameni3@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Antimicrobial Resistance Research Center of Mazandaran University Of Medical Sciences
Full name of responsible person
Dr Alikhani
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
Razi Hospital, Yoosef Reza st., Ghaemshahr
City
Ghaemshahr
Postal code
4765686143
Phone
+98 11 4221 8020
Fax
+98 11 4221 8011
Email
a.alikhani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)